Medical network - August 1, the food and drug supervision bureau attaches great importance to the innovation and development, medical equipment industry to better implement the innovation of medical apparatus and instruments for examination and approval of special program (try out) "(hereinafter referred to as the" innovation program "), concentrated force, improve efficiency, to do a good job of innovation medical instrument special examination and approval, encourage registration applicant focus on research and development innovation, interpretation is just part of the problem are as follows:
1. Time for special approval of innovative medical devices
According to the "innovation procedure", the general administration of food and drug administration has applied for special approval of innovative medical devices before applying for the registration of medical devices, which shall be dealt with in accordance with the corresponding requirements of the innovation program.
2. Whether the first type of medical equipment is subject to the innovation procedure
According to the regulations on the supervision and administration of medical devices (state council order no. 680), the first kind of record management of medical equipment, do not belong to the administrative licensing matters, so the class I medical devices shall not apply to the "innovation program".
The general administration of food and drug administration shall not accept the special examination and approval of the first type of medical devices applying for innovative medical devices; Is the innovation of the food and drug supervision bureau to accept the special request for approval of medical equipment, after examination, if the application products have been defined as class I medical devices, is not carried out in accordance with the "innovation program" for approval.
3. Whether the renewal of the registration/licensing changes is applicable to the innovation program
According to "innovation program" article 12, article 14, article 17, the innovation of medical equipment special approval applies only to the medical device registration management approach "(food and drug supervision administration makes no. 4), the in vitro diagnostic reagents registration management approach" (food and drug supervision administration to 5) clear medical device registration form for the first time, do not apply to the continuation of registration or licensing items change form. |
